Scintigraphy evaluation of colon targeted vitamin formulations
Research type
Research Study
Full title
A proof of concept scintigraphic study to investigate the in vivo performance of an orally delivered colon targeted vitamin formulation in healthy volunteers
IRAS ID
332044
Contact name
Laura Gow
Contact email
Sponsor organisation
BDD Pharma Ltd
Duration of Study in the UK
0 years, 1 months, 29 days
Research summary
Summary of Research
This is a proof of concept, single centre study in up to 12 healthy male and female volunteers. The study is designed to assess the time and location of the release of a vitamin tablet designed to release in the colon. The vitamin tablet contains Vitamin C (220mg), Vitamin B2 (12mg), Vitamin B6 (2.5mg), Vitamin B3 (5.5mg), Vitamin B5 (6.7mg) and Vitamin B9 (10%) on Maltodextrin (5mg).
The primary purpose of this study is to demonstrate the site and time of onset of disintegration of the novel vitamin tablet formulation.
In this study we will use scintigraphic imaging to confirm the site of release in the gastrointestinal tract. To look at this parameter, we will add a small amount of radioactive materials to the tablet. The radioisotope to be used in this study is technetium-99m (99mTc).
Participants will attend a screening visit to confirm eligibility to take part in the study, one assessment visit where they will be dosed with one vitamin tablet and a follow up visit at the end of the study. Participants will attend the study centre fasted on the assessment visit and standardised meals will be provided at set times during the assessment visit.
Summary of Results
Summary of Results Safety The colonic targeted vitamin formulation dosed in this study demonstrated an acceptable safety and tolerability profile with only one possibly related mild adverse event of diarrhoea noted in one participant (N=1) which resolved with pharmacological intervention (loperamide). There were no serious adverse events.
Scintigraphic
GI transit parameters were within normal ranges, with a mean gastric emptying time of 1.3 hours and mean small intestinal transit time of 4.2 hours. Onset of radiolabel release did not occur in the stomach for any of the 12 participants, validating the performance of the functional enteric coat. Onset of radiolabel release was observed in the colon, ileocecal junction or distal regions of the small intestine in all but one of the participants reflecting the delayed onset nature of the formulation employed. The mean onset time of radiolabel release was 5.9 hours following dosing, reflecting gastrointestinal transit times and the pH responsive nature of the enteric coat.REC name
West of Scotland REC 5
REC reference
23/WS/0127
Date of REC Opinion
21 Sep 2023
REC opinion
Further Information Favourable Opinion